US20130066361A1 - Apparatus and methods for sealing a vascular puncture - Google Patents
Apparatus and methods for sealing a vascular puncture Download PDFInfo
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- US20130066361A1 US20130066361A1 US13/610,849 US201213610849A US2013066361A1 US 20130066361 A1 US20130066361 A1 US 20130066361A1 US 201213610849 A US201213610849 A US 201213610849A US 2013066361 A1 US2013066361 A1 US 2013066361A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
- A61B2017/00495—Surgical glue applicators for two-component glue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00637—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/0065—Type of implements the implement being an adhesive
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00672—Locating means therefor, e.g. bleed back lumen
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Abstract
Description
- This application is a continuation of co-pending application Ser. No. 10/982,385, issuing as U.S. Pat. No. 8,262,693, the entire disclosure of which is expressly incorporated by reference herein.
- The present invention relates generally to apparatus and methods for sealing punctures in a body, and more particularly, to apparatus and methods for sealing a vascular puncture extending through tissue into a blood vessel, and to apparatus and methods for delivering a plug into a percutaneous puncture extending from a patient's skin to a blood vessel or other body lumen to seal the puncture.
- Apparatus and methods are known for accessing a patient's vasculature percutaneously, e.g., to perform a procedure within the vasculature, and for sealing the puncture that results after completing the procedure. For example, a hollow needle may be inserted through a patient's skin and overlying tissue into a blood vessel. A guide wire may be passed through the needle lumen into the blood vessel, whereupon the needle may be removed. An introducer sheath may then be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to one or more dilators.
- A catheter or other device may be advanced through the introducer sheath and over the guide wire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate accessing and/or introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss. Upon completing the procedure, the device(s) and introducer sheath may be removed, leaving a puncture extending between the skin and the vessel wall.
- To seal the puncture, external pressure may be applied to the overlying tissue, e.g., manually and/or using sandbags, until hemostasis occurs. This procedure, however, may be time consuming and expensive, requiring as much as an hour of a medical professional's time. It is also uncomfortable for the patient, and may require the patient to remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.
- Various apparatus and methods have been suggested for sealing a percutaneous puncture instead of using external pressure. For example, U.S. Pat. No. 5,108,421 to Fowler discloses a plug that may be delivered into a puncture through tissue. The plug is a cylindrical rod-shaped member which is constructed of a porous, bioabsorbable and expandable hemostatic collagen sponge or a polymerized polylactic acid or polyglycolic acid. In one embodiment, a catheter is inserted through the puncture into the blood vessel. A balloon on the catheter is expanded and retracted until the balloon is disposed adjacent the puncture at the wall of the vessel. The plug may be advanced into the puncture until the plug contacts the balloon. Once the plug is positioned within the puncture, the balloon may be deflated and withdrawn, leaving the plug within the puncture to expand and seal the puncture and/or to promote hemostasis.
- Alternatively, U.S. Pat. Nos. 5,192,302 and 5,222,974 issued to Kensey et al. describe a bioabsorbable collagen plug that may be delivered through an introducer sheath into a puncture site. The disclosed plug, however, may be difficult to position properly with respect to the vessel, which may be significant since it is generally undesirable to expose the collagen material within the bloodstream where it may float downstream and cause an embolism.
- U.S. Pat. No. 6,605,295 describes rods, plugs, crushed or irregularly shaped pieces of substantially dehydrated hydrogel that may be introduced into a lumen or void in a patient's body to seal or plug a biopsy needle track, reinforce weak tissue, or deliver a therapeutic compound. In one embodiment, a plug of dehydrated hydrogel may be deployed into the site of an arteriotomy and allowed to hydrate in the presence of the tissue fluids and blood, to fill the track of the catheter sheath and prevent further bleeding. By swelling to equilibrium hydration, the plug may lock itself firmly in place and thus reduce the risk of formation of a large hematoma at the site of the puncture.
- U.S. Pat. No. 6,703,047 discloses dehydrated hydrogel precursor-based, tissue adherent compositions. The hydrogels may be used, for example, for sealing fluid leaks from tissue, as adherent drug delivery depots, and as means for augmenting and/or supporting tissue. The hydrogels may be administered directly to an open wound site or may be dispensed, e.g., using a non-adhesive backing material, an absorbable backing material, a syringe applicator, a powder atomization or aerosolization system, or a needle-less injector.
- The present invention is directed to apparatus and methods for sealing a puncture in a body, and, more particularly, to apparatus and methods for providing temporary or permanent hemostasis within a vascular puncture extending into a blood vessel, and/or to apparatus and methods for delivering a sealing plug into a percutaneous puncture extending from a patient's skin to a blood vessel or other body lumen.
- In accordance with one embodiment, an apparatus is provided for sealing a puncture extending through tissue that includes a tubular member including a proximal end, a distal end sized for insertion through the puncture, a lumen extending between the proximal and distal ends, and a distal opening in communication with the lumen. A bioabsorbable plug is disposed within the lumen, e.g., adjacent the distal opening, and a bioabsorbable anchor element is disposed within the lumen proximal to the plug. A pusher member is slidable within the lumen of the tubular member for deploying the plug and anchor element through the lumen and out the distal opening of the tubular member.
- In one embodiment, the plug and anchoring element may include material, hydrogel material, that hydrates when exposed to an aqueous physiological environment, the plug hydrating at a more rapid rate than the anchoring element. In addition or alternatively, the plug may be porous and the anchoring element may be the anchoring element may be less porous than the plug. In an exemplary embodiment, the anchoring element may include a substantially rigid body, e.g., formed from air-dried hydrogel, and may include one or more protrusions for securing the anchoring element to surrounding tissue within a puncture.
- In exemplary embodiments, the plug may include a core, e.g., of lyophilized hydrogel, and a coating on at least a portion of the core, e.g., including first and second precursors, that remains in an unreactive state prior to exposure to an aqueous physiological environment in the tissue whereupon the first and second precursors react to form an adherent coating on the core. Optionally, an activating agent, e.g., a pH adjusting material, may be disposed on at least a portion of the core, the activating agent facilitating or initiating reaction of the first and second precursors when exposed to an aqueous physiological environment.
- In accordance with another embodiment, an apparatus is provided for sealing a puncture extending through tissue and communicating with a body lumen that includes a tubular member including a proximal end, a distal end sized for insertion through the puncture and into the body lumen, and a lumen extending between the proximal and distal ends. A bioabsorbable plug may be disposed within the lumen of the tubular member adjacent the distal end and a bioabsorbable anchoring element may be disposed within the lumen of the tubular member proximal to the plug. A pusher member may be movable within the tubular member lumen for deploying the plug and anchoring element out the distal end of the tubular member.
- The pusher member, plug, and anchoring element may include a lumen extending therethrough, and the apparatus may include an elongate positioning member including a proximal end slidable through the plug lumen, the anchoring element lumen, and the pusher member lumen. The positioning member may include a positioning element on a distal end thereof for preventing the positioning element from being removed from the body lumen into the puncture after being deployed within the body lumen and/or for sealing the body lumen from the puncture.
- In accordance with still another embodiment, a method is provided for sealing a puncture extending through tissue to a body lumen. A positioning member may be introduced into the puncture until a positioning element thereon is disposed within the body lumen, and the positioning member may be retracted until the positioning element contacts a wall of the body lumen.
- A bioabsorbable plug may be delivered into the puncture over the positioning member until the plug is disposed proximate the positioning element, and an anchoring element may be delivered into the puncture above the plug to prevent the plug from moving proximally within the puncture.
- In one embodiment, the plug and anchoring element are carried within a tubular member, and the plug and anchoring element may be delivered into the puncture simultaneously by advancing the tubular member into the puncture. The tubular member may be retracted while maintaining the plug and the anchoring element within the puncture to expose the plug and the anchoring element within the puncture, e.g., adjacent the body lumen. Optionally, the plug may be cinched or otherwise compressed against a wall of the body lumen.
- When the plug and/or anchoring element are exposed to bodily fluid when the tubular member is retracted, the plug and/or anchoring element may hydrate to enhance sealing the puncture. For example, the plug and the anchoring element may include hydrogel material, the anchoring element hydrating more slowly than the plug when exposed within the puncture. Optionally, a sealing compound, e.g., a liquid hydrogel, may be delivered into the puncture after delivering the plug into the puncture, e.g., to enhance sealing the puncture.
- Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
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FIG. 1 is an exploded side view of an apparatus for delivering a plug into a puncture through tissue. -
FIGS. 2A and 2B are cross-sectional views of the apparatus ofFIG. 1 , with a cartridge carrying a plug and anchor in proximal and distal positions, respectively. -
FIG. 3A is a perspective view of an exemplary embodiment of a plug that may be delivered using the apparatus ofFIG. 1 . -
FIG. 3B is a cross-sectional detail of the plug ofFIG. 3A . -
FIG. 4 is a perspective view of an exemplary embodiment of an anchoring element that may be delivered using the apparatus ofFIG. 1 . -
FIGS. 5A-5F are cross-sectional views of a patient's body, showing a method for sealing a puncture extending from the patient's skin to a blood vessel using the apparatus ofFIG. 1 . - Turning to the drawings,
FIGS. 1 , 2A, and 2B show an exemplary embodiment of anapparatus 101 for sealing a puncture through tissue. Generally, theapparatus 101 includes a cartridge or othertubular member 120 and a plunger, cincher, orother pusher member 130. Thecartridge 120 generally carries aplug 2 and ananchoring element 102, such as those described further below. In addition, theapparatus 101 may include apositioning member 140, a delivery, access, orintroducer sheath 20, and/or other components, e.g., a needle and/or guidewire for creating a puncture (not shown), and/or a source of sealing compound (also not shown). - The
introducer sheath 20 may be a substantially rigid, semi-rigid, and/or flexible tubular body, including aproximal end 22, adistal end 24 sized for insertion into a puncture through tissue, and alumen 26 extending between the proximal and distal ends 22, 24. Thedistal end 24 may be tapered and/or may include a substantially atraumaticdistal tip 25 for facilitating advancement through a puncture. Theintroducer sheath 20 may include a handle orhub 23 on theproximal end 22, and/or one or more seals on theproximal end 22, e.g., a hemostatic seal (not shown) that prevents proximal flow of blood or other fluids, yet accommodates inserting one or more instruments (also not shown) into thelumen 26 of theintroducer sheath 20. - The
cartridge 120 may be an elongate tubular body including aproximal end 122, adistal end 124, and alumen 126 extending between the proximal anddistal ends cartridge 120 may include a tapereddistal tip 125 and/or an enlarged handle orhub 123 on theproximal end 122. Thecartridge 120 may be substantially rigid, semi-rigid, or flexible, e.g., such that thecartridge 120 may be advanced through theintroducer sheath 20 or otherwise into a puncture through tissue. - The
pusher member 130 may also be an elongate tubular body, e.g., a plunger or catheter, including aproximal end 132, adistal end 134, and alumen 136 extending between the proximal anddistal ends pusher member 130 may have a size for slidable insertion into thelumen 126 of thecartridge 120. Thedistal end 134 of thepusher member 130 may terminate in a substantially bluntdistal tip 135, e.g., to facilitate contacting, pushing, and/or “cinching” theplug 2 within the puncture, as described further below. - The
pusher member 130 may be substantially rigid, semi-rigid, and/or substantially flexible, having sufficient column strength to allow proximal movement of thecartridge 120 relative to theplug 2 without buckling thepusher member 130. Thepusher member 130 may also include alumen 136 extending between theproximal end 132 and thedistal end 134, e.g., to accommodate thepositioning member 140, a guidewire (not shown), a flowable sealing compound, and/or other fluid. - The
plug 2 may be disposed within thelumen 126 of thecartridge 120 proximate to thedistal end 124, e.g., immediately adjacent thedistal tip 125. Thelumen 126 may be sized such that theplug 2 is slidable therein, e.g., able to traverse distally from thecartridge 120 during delivery, as described further below. The anchoringelement 102 may also be disposed within thelumen 126 of thecartridge 120 proximal to theplug 2, e.g., immediately adjacent theplug 2. - In the embodiment shown in
FIG. 1 , the positioningmember 140 may be a guidewire and/or other solid or hollow elongate body, including aproximal end 142, adistal end 144, and apositioning element 146 on thedistal end 144. Thepositioning element 146 may be an expandable element, such as a wire mesh structure, an expandable frame, and/or a balloon member (not shown). Optionally, thepositioning element 146 may include a skin or other covering (not shown) on at least a proximal portion thereof, thereby making thepositioning element 146 substantially nonporous. - The
positioning element 146 may be selectively expandable, e.g., using a pull wire, a source of inflation media (e.g., coupled to a lumen, not shown, extending through the positioningmember 140 to a balloon or other inflatable positioning element, also not shown), or other actuator (also not shown) operable from theproximal end 142 of thepositioning member 140. Alternatively, thepositioning element 146 may be biased to an enlarged condition, but may be compressed to a contracted condition, e.g., by an overlying sleeve or other constraint (not shown). The constraint may be removed to expose the expandable element, allowing the expandable element to automatically expand to the enlarged condition. Additional information on expandable structures that may be incorporated intopositioning member 140 may be found in U.S. Pat. Nos. 6,238,412 and 6,635,068, in co-pending application Ser. No. 10/143,514, published as Publication No. US 2003/0078616 A1, and 10/975,205, filed Oct. 27, 2004 and entitled “Apparatus and Methods for Delivering Sealing Materials During a Percutaneous Procedure to Facilitate Hemostasis” (assigned attorney matter no. ACI-008). The entire disclosures of these references are expressly incorporated herein by reference. - Turning to
FIGS. 2A and 2B , thedelivery apparatus 101 may be used to position and deliver theplug 2 within a puncture, e.g., extra-vascularly just above or otherwise adjacent to an arteriotomy in a blood vessel or other body lumen communicating with the puncture, as explained further below. In one embodiment, as shown inFIG. 2A , the cartridge 120 (along with thepusher member 130,plug 2, and anchoring element 102) may be initially provided on aproximal end 142 of thepositioning member 140. Thecartridge 120 may be slidable distally along the positioningmember 140, e.g., until thedistal end 124 of thecartridge 120 is disposed adjacent thepositioning element 146, as shown inFIG. 2B . - Optionally, the positioning
member 140 and/orpusher member 130 may include one or more detents that engage when thecartridge 120 reaches a predetermined location along the positioningmember 140, e.g., to limit subsequent movement of thepusher member 130 relative to thepositioning member 140. For example, as shown inFIGS. 2A and 2B , the positioningmember 140 may include a ring, tab, or other raisedelement 145, and thepusher member 130 may include a living hinge, tab, orother latch element 137, e.g., onproximal end 132. - For example, the
latch element 137 may simply be an annular notch in theproximal end 132 of thepusher member 130 to bias theproximal end 132 inwardly. Thering 145 may be provided at a predetermined location on thepositioning member 140, e.g., a predetermined distance from thepositioning element 146 that corresponds to a length of thepusher member 130. As the cartridge 120 (and consequently the pusher member 130) is advanced, e.g., until theplug 2 is disposed adjacent thepositioning element 146, thelatch element 137 may pass freely over the raisedelement 145. Thereafter, thelatch element 137 may prevent thepusher member 130 from being retracted again past thering 145, due to the blunt edge of thelatch element 137 abutting thering 145 on thepositioning member 140. - Alternatively, the
cartridge member 120 andpusher member 130 may be provided initially adjacent thedistal end 144 of thepositioning member 140, as shown inFIG. 2B . In this alternative, thepusher member 130 andpositioning member 140 may include the cooperatingdetents 133, 145 to prevent proximal movement of thepusher member 130 relative to thepositioning member 140. Alternatively, thepusher member 130 may be otherwise fixed relative to thepositioning member 140, for example, mechanically bonded, chemically bonded, and the like. Thus, thedistal end 134 of thepusher member 130 may be fixed a predetermined distance proximal to thepositioning element 146, e.g., to provide theplug 2 immediately adjacent thepositioning element 146, as shown inFIG. 2B . - Turning to
FIGS. 3A and 3B , in one embodiment, theplug 2 may include a carrier orcore 4, having first and second hydrogel precursors disposed thereon in an unreactive state, thereby providing anadherent coating 6. Theplug 2 may have a solid or hollow cylindrical shape, a disk shape, or other shapes or cross-sections, such as elliptical, triangular, square, conical, disk, polygonic shapes, and the like. - As best seen in
FIG. 3A , theplug 2 may include alumen 10 extending between proximal and distal ends 14, 16 thereof, thereby defining alongitudinal axis 18. Thelumen 10 may be created when thecore 4 is formed, e.g., if thecore 4 is rolled from one or more sheets or layers of material or formed by molding. Alternatively, thelumen 10 may formed by boring into or otherwise removing material from an already formedsolid core 4. Thelumen 10 may be dimensioned such that thepositioning member 140, a guidewire or other instrument (not shown) may slide or otherwise pass through theplug 2. - The
core 4 may be formed from a biocompatible and/or bioabsorbable material, for example, a porous, bioabsorbable foam or other solid material. In one embodiment, thecore 4 may be formed from a biocompatible and/or bioabsorbable hydrogel, e.g., polyethylene glycol (“PEG”), or other synthetic material. In another embodiment, thecore 4 may be formed from a lyophilized (i.e., freeze-dried) PEG polymer that contains hydrolytically degradable chemical groups. The lyophilized PEG polymer, e.g., including a macroporous polymer network, may uptake fluid and expand when exposed to an aqueous environment. The magnitude of expansion or swelling (pre to post hydration) may be significant, e.g., between about two and ten times (2×-10×) its lyophilized size based on volume. - In addition or alternatively, the
core 4 may include pro-thrombotic material, e.g., including one or more biological pro-thrombotics, such as collagen, fibrin, carboxymethylcellulose, oxidized cellulose, alginates, gelatin, or other protein-based material, and/or synthetic materials, such as polyglycolic acids (PGA's), polyactides (PLA's), polyvinyl alcohol, and the like. The material of thecore 4 may be at least partially absorbed by the body over time, e.g., over a period of days, weeks, or months. - Optionally, the
core 4 may include therapeutic and/or pharmaceutical agents, e.g., to promote healing, prevent infection and/or other adverse medical events, and the like. Such agents may be embedded in the core material and/or applied as one or more coatings or layers. In addition, the material of thecore 4 may have a substantially uniform composition or the composition may be varied, e.g., along its length and/or within underlying layers within thecore 4. - The first and
second hydrogel precursors 6 may remain in the unreactive state, e.g., before or until exposure to an aqueous physiological environment. An aqueous physiological environment may exist, for example, inside a puncture track extending through tissue. Blood or other bodily fluids that contact the precursor-laden carrier may initiate a hydrogel forming reaction between the two precursors. The reaction of the hydrogel precursors may form a cross-linked adhesive or tacky coating that may aid in retaining theplug 2 within a puncture after deployment and/or in facilitating hemostasis within the puncture. - The first and
second hydrogel precursors 6 may be loaded onto thecore 4, e.g., by wicking a mixture of the liquid hydrogel precursors onto thecore 4. Depending on the material used, the hydrogel precursors may initially be a solid dehydrated material, e.g., a powder, that may be heated above its melting point to form a liquid suitable for wicking. For example, the first and second hydrogel precursors may be sufficiently mixed before being loaded onto thecore 4. - Alternatively, the first and second precursors may be provided in a liquid form into which the
core 4 may be dipped, that may be poured onto thecore 4, and/or otherwise applied to thecore 4 together or successively. For example, the first and second precursors may be dissolved in a solvent that may then be applied to thecore 4. In either case, once the first and second hydrogel precursors are loaded onto thecore 4, the first and second hydrogel precursors may be in a solid or semi-solid state. - The first hydrogel precursor may include any number of hydrogel precursor materials, such as those disclosed in U.S. Pat. Nos. 6,152,943, 6,165,201, 6,179,862, 6,514,534, 6,379,373, 6,703,047, and in co-pending application Ser. Nos. 10/010,715 filed Nov. 9, 2001, 10/068,807 filed Feb. 5, 2002, and 10/454,362, filed Jun. 4, 2003. The disclosures of these references and any others cited therein are expressly incorporated by reference herein. For example, in one embodiment, the first hydrogel precursor may include a four arm, 10 kDalton PEG with reactive ester end groups or an eight arm, 20 kDalton PEG amine. Alternatively, the first hydrogel precursor may include a bioabsorbable star polymer having a complementary cross-linking species such as, for example, an amino acid with reactive end groups, e.g., lysine, dilysine, trilysine, etc.
- The second hydrogel precursor may include any number of hydrogel precursor materials, e.g., a material reactive with the first precursor material once exposed within a hydrous or aqueous environment, such as those materials disclosed above and in the references incorporated by reference above. For example, the second precursor may be the other of an eight arm, 20 kDalton PEG amine or a four arm, 10 kDalton PEG ester. Alternatively, the second precursor may be the complementary cross-linking species of a bioabsorbable star polymer, such as an amino acid with reactive end groups, e.g., lysine, dilysine, trilysine, etc.
- Optionally, an activating
agent 8, e.g., a pH adjusting or activating agent, may also be disposed on thecore 4, e.g., to initiate, accelerate, or otherwise enhance the reaction of theprecursors 6. For example, thepH activating agent 8 may create a localized change in pH after exposure to a hydrous or aqueous environment. In an exemplary embodiment, thepH activating agent 8 may include solid borate crystals, such as Na2B4O7.10H2O, although different salt-based or other materials that alter the localized pH value may be employed. Alternatively, otherpH adjusting agents 8 may be used, such as sodium bicarbonate, and the like. - In one embodiment, the
pH activating agent 8 may be loaded onto thecore 4 by physically contacting solid borate crystals, powder, or other particles onto the precursor-laden (first and second hydrogel precursors) core. For example, thecore 4 may simply be rolled over apH activating agent 8 with sufficient force to embed thepH activating agent 8 into the exterior surface of thecore 4. Alternatively, thepH activating agent 8 may be adhered to the exterior surface of thecore 4, e.g., by pressing particles of thepH activating agent 8 into the exterior surface, by using an adhesive (e.g., that is substantially inert or unreactive with the first or second precursors), and the like. Additional information on plugs that may be provided are disclosed in co-pending application Ser. No. 10/982,387, filed Nov. 5, 2004, entitled “Apparatus and Methods for Sealing a Vascular Puncture,” the entire disclosure of which is expressly incorporated herein by reference. - In other embodiments, laminate structures may be used for the
plug 2, e.g., a sheet including multiple layers of different components, such as one or more of the components described above, may be formed, and the sheet may be rolled into a tubular or solid cylindrical structure. An exemplary embodiment of such a sheet may include three layers, e.g., a first layer of lyophilized hydrogel, a second layer of two-part hydrogel adherent material, and a third layer of lyophilized hydrogel. The layers may be substantially uniform, or one or more of the layers may vary in thickness, e.g., along their lengths. For example, in one embodiment, the layer(s) may become progressively thicker from one edge corresponding to theproximal end 14 of theplug 2 to the opposite edge corresponding to thedistal end 16 of theplug 2. Thus, theplug 2 may have a frustoconical shape (not shown), rather than a substantially uniform cylindrical shape. - In another embodiment, a layer of lyophilized hydrogel may be provided, and an adherent layer, e.g., including two hydrogel precursors in an initially unreactive state, may be applied to one surface of the layer of lyophilized hydrogel. A pH adjusting agent, e.g., borate crystals, may be embedded or otherwise applied to the opposite surface of the layer of lyophilized hydrogel. Thus, in this embodiment, the pH adjusting agent may be substantially segregated from the adherent layer. This may be desirable to prevent the pH adjusting agent from initiating reaction of the materials of the adherent layer prematurely, which may otherwise occur to some degree, even absent an aqueous environment.
- In addition or alternatively, the composition of the
plug 2 may be varied along its length. For example, material on or adjacent thedistal end 16 of theplug 2 may more rapidly rehydrate and/or otherwise expand than material on or adjacent theproximal end 14 of theplug 2. In an exemplary embodiment, a composition of hydrogel may be provided adjacent thedistal end 16 that is more porous than the hydrogel provided adjacent theproximal end 14, which may accelerate expansion of thedistal end 16 compared to theproximal end 14. - In addition or alternatively, different hydrogel compositions may be used such that the
distal end 16 is capable of absorbing more liquid than theproximal end 14, such that thedistal end 16 swells to a greater size theproximal end 14. Thus, in its hydrated, final state, theplug 2 may have a frustoconical shape (not shown), or other shape in which thedistal end 16 is substantially larger than theproximal end 14. This configuration may facilitate and/or enhance compaction against an arteriotomy or otherwise enhance sealing. In addition or alternatively, the material of theplug 2 may be compacted before or after being formed into the plug shape, e.g., to change its shape from a substantially uniform cylindrical shape and/or to change the density of theplug 2 along its length. - Turning to
FIG. 4 , an exemplary embodiment of ananchoring element 102 is shown. Generally, the anchoringelement 102 includes abody 104 including alumen 110 and one ormore protrusions 108. For example, as shown inFIG. 4 , theprotrusions 108 include a plurality of barbs extending radially outwardly from thebody 104. As shown, theprotrusions 108 may extend transversely from thebody 104, e.g., laterally and proximally. Thus, when theprotrusions 108 are embedded in or otherwise contact surrounding tissue, theprotrusions 108 may limit proximal movement of theanchoring element 102. - The anchoring
element 102 may be formed from a substantially rigid bioabsorbable material. For example, in one embodiment, the anchoringelement 102 may be formed from dehydrated hydrogel material, e.g., air-dried hydrogel. When a hydrogel material is air-dried (as opposed to freeze-dried), the material may collapse in upon itself, e.g., resulting in a substantially nonporous structure that is substantially rigid. The resulting structure may be relatively nonporous, e.g., compared to lyophilized hydrogel, such as those described above for theplug 2. Thus, although capable of rehydrating when exposed to an aqueous environment, the anchoringelement 102 may hydrate at a slower rate than theplug 2, e.g., on the order of several minutes. - Because of its rigidity, the material may then be formed into a desired shape, e.g., by laser cutting, sawing, machining, grinding, and the like. Thus, a desired volume of hydrogel may be air-dried, and then the resulting piece of hydrogel may be formed, e.g., to create the
body 104,lumen 110, andprotrusions 108. - Alternatively, the anchoring
element 102 may be formed from other bioabsorbable materials that are sufficiently rigid to engage tissue surrounding a puncture and anchor theanchoring element 102 and plug 2 within the puncture. For example, synthetic materials may be used, such as polyglycolic acids (PGA's), polyactides (PLA's), and polyvinyl alcohol. In further alternatives, the anchoringelement 102 may include pro-thrombotic material, e.g., including one or more biological pro-thrombotics, such as collagen, fibrin, carboxymethylcellulose, oxidized cellulose, alginates, gelatin, or other protein-based material. - In a further alternative, the anchoring
element 102 may be formed from biocompatible, but not bioabsorbable material. For example, the anchoringelement 102 may be formed from metal, such as stainless steel, or plastics, that may remain within a patient's body indefinitely. The anchoringelement 102 may be of sufficient size to engage tissue surrounding a puncture, yet be small enough to remain unobtrusively within the patient's body after the procedure, i.e., after theplug 2 has been absorbed and/or the puncture has healed. - Turning to
FIGS. 5A-5F , an exemplary method is shown for sealing apuncture 90, e.g., using theapparatus 101 described above to deliver aplug 2 andextra-vascular anchoring element 102, such as any of the embodiments described above. Generally, thepuncture 90 extends from a patient'sskin 92 through interveningtissue 96, e.g., to abody lumen 94. In an exemplary embodiment, thepuncture 90 may be a percutaneous puncture communicating with ablood vessel 94, such as a femoral artery, carotid artery, and the like. - In an exemplary method, the
puncture 90 may be created using known procedures, e.g., using a needle, guidewire, one or more dilators, and the like (not shown). Anintroducer sheath 20 may be advanced through thepuncture 90 into thevessel 94, e.g., to provide access into thevessel 90 for one or more instruments, and/or allow one or more diagnostic and/or interventional procedures to be performed via thevessel 90, as is known in the art. Upon completing the procedure(s) via thevessel 94, any instruments and/or the introducer sheath (not shown) may be removed from thepuncture 90. - With reference to
FIG. 5A , apositioning member 140 may be introduced into and/or through thelumen 26 of theintroducer sheath 20, e.g., with the expandable frame orother positioning element 146 thereon in a collapsed condition. The cartridge 120 (along with theplug device 102 and pusher member 130) may be provided initially on theproximal end 142 of the positioning member 140 (not shown inFIG. 5A for clarity, seeFIG. 2A ). Thus, thecartridge 120 may initially be located outside thepuncture 90 as thepositioning member 130 is advanced into thepuncture 90. - Alternatively, the
cartridge 120 may be carried on thedistal end 144 of the positioning member 140 (as shown inFIG. 2B ), e.g., such that the cartridge 120 (along with theplug device 102 and pusher member 130) are introduced simultaneously with the positioning member 140 (not shown inFIG. 5A ). In a further alternative, thecartridge 120 may be provided separate from the positioning member 140 (not shown). After thepositioning member 140 is advanced into thepuncture 90, the shaft of thepositioning member 140 may extend proximally from theproximal end 22 of theintroducer sheath 20 out of thepuncture 90. Theproximal end 142 of thepositioning member 140 may be back-loaded into thecartridge 120, e.g., through thelumens plug 2, anchoringelement 102, andpusher member 130. - Still referring to
FIG. 5A , thedistal end 144 of thepositioning member 140 may be inserted through the puncture 90 (via the introducer sheath 20) and into the vessel 94 (shown in phantom). Turning toFIG. 5B , once thepositioning element 146 is disposed within thevessel 94, i.e., beyond thedistal end 24 of theintroducer sheath 20, thepositioning element 146 on thedistal end 144 of thepositioning member 140 may be expanded or otherwise deployed to an enlarged condition. After expanding thepositioning element 146, the positioningmember 140 may be at least partially withdrawn until thepositioning element 146 contacts the wall of thevessel 94, e.g., to substantially seal thevessel 94 from thepuncture 90. - In an exemplary method, this may involve a two-step process (although it may be completed in a single continuous action). First, with expanded
positioning element 146, the positioningmember 140 is withdrawn until it contacts thedistal end 24 of theintroducer sheath 20, which may provide a first tactile feedback to the user (that thepositioning element 146 has contacted theintroducer sheath 20 based upon the increased weight and/or resistance to proximal movement). The positioningmember 140 may be withdrawn further until thepositioning element 146 contacts the wall of thevessel 94, thereby providing a second tactile feedback. Theintroducer sheath 20 may be pulled proximally by thepositioning element 146 as thepositioning member 120 is withdrawn, e.g., until thedistal end 24 of theintroducer sheath 20 is withdrawn from thevessel 94 into thepuncture 90, as shown inFIG. 5B . - Proximal tension may be applied and/or maintained on the
positioning member 140 to hold thepositioning element 146 against the wall of thevessel 94, e.g., to seal thepuncture 90 from thevessel 94. The proximal tension may be maintained manually or using a tensioner device (not shown) to provide temporary hemostasis, e.g., during the subsequent steps. Exemplary tension devices are disclosed in co-pending application Ser. No. 10/806,952, filed Mar. 22, 2004, the entire disclosure of which is expressly incorporated herein by reference. - Turning to
FIG. 5C , the cartridge 120 (carrying theplug 2 and anchoring element 102) may be advanced distally over the positioningmember 140 into thepuncture 90. For example, thecartridge 120 may be advanced through theintroducer sheath 20 until ahub 123 of thecartridge 120 abuts ahub 23 on theintroducer sheath 20, as shown inFIG. 5C . As explained above with reference toFIGS. 2A and 2B , as thecartridge 120 is advanced, thepusher member 130 may slide over the positioningmember 140 until thelatch element 137 on thepusher member 130 passes over thering 145 on thepositioning member 140. This may prevent subsequent proximal movement of thepusher member 130 relative to thepositioning member 140. - Now referring to
FIG. 5D , while proximal tension is maintained on thepositioning member 140, thepusher member 130 is maintained with thedistal end 134 immediately adjacent theanchoring element 102, and theintroducer sheath 20 andcartridge 120 are retracted proximally to expose or otherwise deploy theplug 2 and anchoringelement 102 within thepuncture 90. Thepusher member 130 may serve as a stop that prevents theplug 2 and anchoringelement 102 from moving proximally while theintroducer sheath 20 andcartridge 120 are withdrawn. - Alternatively, if the
pusher member 130 is not provided initially within thecartridge 120, thepusher member 130 may be advanced distally into thelumen 126 of thecartridge 120, e.g., until thedistal end 134 of thepusher member 130 is proximally adjacent theanchoring element 102. The cartridge 120 (and introducer sheath 20) may then be withdrawn, while maintaining thepusher member 130 in position to deploy theplug 2 and anchoringelement 102 successively within thepuncture 90. - In one embodiment, the user of the
delivery apparatus 101 may position his or her thumb on hub 133 of thepusher member 130 to maintain its position while theintroducer sheath 20 andcartridge 120 are retracted by pulling onhub 23, e.g., using his or her index and middle fingers. For example, as shown inFIG. 5D , with thehub 123 of thecartridge 120 abutting thehub 23 of theintroducer sheath 20, thehub 23 of theintroducer sheath 20 may be held and withdrawn, thereby causing thecartridge 120 to be withdrawn simultaneously. Alternatively, theintroducer sheath 20 may be removed first, and then thecartridge 120 may be removed. Thecartridge 120 andintroducer sheath 20 may be removed entirely from thepuncture 90 or only sufficiently to expose theplug 2 and anchoringelement 102 within thepuncture 90. - Optionally, as shown in
FIG. 5E , theplug 2 may be cinched or otherwise compressed within thepuncture 90, e.g., by advancing thepusher member 130 distally to press the anchoringelement 102 against theplug 2 and theplug 2 against the wall of thevessel 94 and/or against thepositioning element 146. This may cause theplug 2 to expand radially outwardly and/or seal against the arteriotomy, e.g., to enhance sealing thepuncture 90 from thevessel 94. - After delivering the
plug 2 and anchoringelement 102, the proximal tension on thepositioning member 140 may be released and/or thepositioning element 146 may be collapsed to its collapsed state. For example, thepositioning element 146 may be mechanically collapsed or deflated. After thepositioning element 146 is collapsed, the positioning member 140 (and consequently the positioning element 146) may be slowly withdrawn through thelumens plug 2, the anchoringelement 102, and thepusher member 130, respectively. - While the positioning
member 140 is withdrawn, thepusher member 130 may be maintained to serve as a stop and prevent proximal migration of theplug 2 and/or anchoringelement 102 within thepuncture 90. In embodiments where theplug 2 includes an adherent layer (not shown inFIG. 5D ), the “sticky” adherent layer may also aid in securing the plug to the tissue surrounding thepuncture 90 to prevent migration. In addition or alternatively, theprotrusions 108 on theanchoring element 102 may engage the surrounding tissue to prevent migration of theplug 2. - After removing the
positioning member 140, thepusher member 130 may be withdrawn, leaving theplug 2 and anchoringelement 102 in place. If desired, e.g., if bleeding occurs proximally through thelumen 136 of thepusher member 130, liquid hydrogel or other sealing compound may be delivered into thepuncture 90 above and/or around theplug device 102, to assist in achieving permanent hemostasis. - For example, as shown in
FIG. 5F , a source of sealing compound, e.g., asyringe assembly 50 carrying liquid sealing compound components, may be coupled to theproximal end 132 of thepusher member 130 and sealingcompound 99 may be delivered into thepuncture 90 above and/or around theplug 2 and/or anchoringelement 102. Optionally, thepusher member 130 may be retracted proximally as the sealingcompound 99 is delivered to at least partially fill thepuncture 90 with the sealingcompound 99. - When the
positioning element 146 is collapsed and/or removed, blood and/or other fluid within thevessel 94 may enter thepuncture 90, thereby exposing theplug 2 and anchoringelement 102 to an aqueous physiological environment. The aqueous physiological environment may wet theplug 2 and anchoringelement 102, thereby initiating rehydration of the materials of theplug 2 and/or anchoringelement 102 and/or initiating a reaction between the first and second precursors (or other adherent coating) on theplug 2. - For example, with additional reference to
FIG. 3 , the fluid may dissolve the activatingagent 8, changing the pH of the fluid to initiate the first andsecond hydrogel precursors 6 reacting with one another. The reaction of the first andsecond hydrogel precursors 6 may form an adhesive or “sticky” hydrogel coating that may bond or otherwise attach to tissue surrounding thepuncture 90, which may facilitate retaining theplug 2 in place within thepuncture 90. In addition, if theplug 2 includes lyophilized hydrogel, the hydrogel may expand or swell as it hydrates to further aid in retaining theplug 2 within thepuncture 90 and/or enhance sealing thepuncture 90. - In one embodiment, the
plug 2 and anchoringelement 102 both include dehydrated hydrogel, theplug 2 including lyophilized hydrogel, and theanchoring element 102 including air-dried hydrogel. In this embodiment, because theanchoring element 102 is less porous, it does not hydrate as rapidly as theplug 2. This may be desirable to ensure that the anchoringelement 102 retains its rigidity and shape initially, e.g., for the several minutes or hours it takes for theanchoring element 102 to hydrate. Theplug 2 may hydrate and expand more rapidly than the anchoringelement 102, e.g., within seconds or minutes to enhance sealing of thepuncture 90. - Because the
anchoring element 102 may retain its shape and rigidity for several minutes or even hours after being delivered, theprotrusions 108 of theanchoring element 102 may engage the surrounding tissue (particularly as the tissue recoils inwardly into the puncture 90), thereby preventing theanchoring element 102 from moving proximally (and optionally distally) within thepuncture 90. With the anchoringelement 102 secured within thepuncture 90, theplug 2 may be unable to move proximally within thepuncture 90, but instead may contact theanchoring element 102. Thus, the anchoringelement 102 may prevent theplug 2 from moving away from the arteriotomy, e.g., if the patient becomes ambulatory or is otherwise moved in a manner that may otherwise disturb theplug 2. - The material of the
plug 2 and anchoringelement 102 may be at least partially absorbed by the body over time, e.g., over a period of days, weeks, or months, as is known in the art. Additional methods for delivering theplug 2 and anchoringelement 102 are disclosed in co-pending application Ser. No. 10/982,387, incorporated by reference above. Although this application does not disclose an extra-vascular anchoring element, it will be appreciated that similar methods may be used to deliver both theplug 2 and theanchoring element 102 as those used to deliver theplug 2 alone. - While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.
Claims (25)
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Also Published As
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EP1807131A1 (en) | 2007-07-18 |
CA2583238A1 (en) | 2006-05-18 |
EP1807131B1 (en) | 2018-09-05 |
JP2008518743A (en) | 2008-06-05 |
US8262693B2 (en) | 2012-09-11 |
US20060100664A1 (en) | 2006-05-11 |
WO2006052612A1 (en) | 2006-05-18 |
US8945178B2 (en) | 2015-02-03 |
CA2583238C (en) | 2015-12-29 |
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